Validation (drug manufacture), documenting that a process or system meets its pre-determined specifications and quality attributes
Verification and validation, in engineering,` confirming that a product or service meets the needs of its users
Design qualification (DQ)- Demonstrates that the proposed design (or the existing design for an off-the-shelf item) will satisfy all the requirements that are defined and detailed in the User Requirements Specification (URS). Satisfactory execution of the DQ is a mandatory requirement before construction (or procurement) of the new design can be authorised.
Installation qualification (IQ) – Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.
Operational qualification (OQ) – Demonstrates that all facets of the process or equipment are operating correctly.
Performance qualification (PQ) – Demonstrates that the process or equipment performs as intended in a consistent manner over time.
- Component qualification (CQ) – is a relatively new term developed in 2005. This term refers to the manufacturing of auxiliary components to ensure that they are manufactured to the correct design criteria. This could include packaging components such as folding cartons, shipping cases, labels or even phase change material. All of these components must have some type of random inspection to ensure that the third party manufacturer's process is consistently producing components that are used in the world of GMP at drug or biologic manufacturer.